P1300 Efficacy and Safety of Daclatasvir in Combination With Asunaprevir (Dcv+asv) in Cirrhotic and Non-Cirrhotic Patients With HCV Genotype 1b: Results of the Hallmark Dual Study

Kao, J.-H.; Heo, June Seok; Yoffe, Boris; Sievert, William; Jacobson, Ira M.; Bessone, Fernando; Peng, Cheng‐Yuan; Roberts, Stuart; Yoon, K.T.; Kopit, Justin; Linaberry, Misti; Noviello, Stephanie; Hughes, Eric; Manns, MP

doi:10.1016/s0168-8278(14)61467-7

Cited by 9 publications

(5 citation statements)

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“…No meaningful differences in safety were described between cirrhotic and non-cirrhotic patients. Overall, most reported AEs were headache, fatigue, nausea, and diarrhea (≥10 %) [ 69 ].…”

Section: Efficacy and Safetymentioning

confidence: 99%

Pharmacokinetics, Efficacy, and Safety of Hepatitis C Virus Drugs in Patients with Liver and/or Renal Impairment

et al. 2016

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Hepatitis C virus (HCV)-infected patients often suffer from liver cirrhosis, which can be complicated by renal impairment. Therefore, in this review we describe the treatment possibilities in HCV patients with hepatic and renal impairment. Cirrhosis alters the structure of the liver, which affects drug-metabolizing enzymes and drug transporters. These modifications influence the plasma concentration of substrates of drugs metabolized/transported by these enzymes. The direct-acting antivirals (DAAs) are substrates of, for example, cytochrome P450 enzymes in the liver. Most DAAs are not studied in HCV-infected individuals with decompensated cirrhosis, and therefore awareness is needed when these patients are treated. Most DAAs are contraindicated in cirrhotic patients; however, patients with a Child-Pugh score of B or C can be treated safely with a normal dose sofosbuvir plus ledipasvir or daclatasvir, in combination with ribavirin. Patients with renal impairment (glomerular filtration rate [GFR] <90 mL/min) or who are dependent on dialysis often tolerate ribavirin treatment poorly, even after dose adjustments. However, most DAAs can be used at the normal dose because DAAs are not renally excreted. To date, grazoprevir plus elbasvir is the preferred DAA regimen in patients with renal impairment as data are pending for sofosbuvir patients with GFR <30 mL/min (as for ledipasvir and velpatasvir). However, sofosbuvir has been used in a small number of patients with severe renal impairment and, based on these trials, we recommend sofosbuvir 400 mg every day when no other DAA regimen is available. Ledipasvir and velpatasvir are not recommended in patients with severe renal impairment.

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“…No meaningful differences in safety were described between cirrhotic and non-cirrhotic patients. Overall, most reported AEs were headache, fatigue, nausea, and diarrhea (≥10 %) [ 69 ].…”

Section: Efficacy and Safetymentioning

confidence: 99%

Pharmacokinetics, Efficacy, and Safety of Hepatitis C Virus Drugs in Patients with Liver and/or Renal Impairment

et al. 2016

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“…In patients who were nonresponders to prior interferon‐based therapy (31% had cirrhosis) or were ineligible or intolerant of interferon (47% had cirrhosis), SVR12 rates were 82%. Overall, the presence or absence of cirrhosis had little effect on SVR rates, except perhaps in prior nonresponders . The phase III trials of daclatasvir + asunaprevir + beclabuvir in genotype 1 patients are the UNITY trials (Table ), for which preliminary results were recently released.…”

Section: Recent and Emerging Major Clinical Trialsmentioning

confidence: 99%

Interferon‐free, direct‐acting antiviral therapy for chronic hepatitis C

Gutiérrez

Lawitz

Poordad

2015

Journal of Viral Hepatitis

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The treatment environment for chronic hepatitis C has undergone a revolution, particularly in genotype 1. Gone are interferon-based therapy and its associated tolerability challenges, inadequate response rates and numerous baseline factors that affect response to therapy. New and emerging treatment regimens employ all-oral combinations of direct-acting antiviral agents, and results of clinical trials suggest that these regimens routinely achieve cure rates >90%, even in patients who failed prior interferon-based triple therapy. In 2015, three all-oral FDA-approved regiments will be available for genotype 1 (sofosbuvir /ledipasvir, sofosbuvir/simeprevir, and paritaprevir/r/ombitasvir/dasabuvir). Furthermore, new treatment combinations appear to be more tolerable and require shorter duration of therapy. We provide an overview of the classes of direct-acting antiviral agents (DAAs), the clinical factors affecting their integration into combination therapies and recent findings from trials of such combination therapies in patients with genotype 1 HCV infection.

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“…However, in those with baseline NS5A RAVs, which limit the activity of daclatasvir, the SVR rate fell to just 40%. With additional research, we may learn that NS5A RAV testing should be a requirement for use of this regimen, particularly given that it is a frequent finding, occurring in 13% to 20% of genotype 1 patients ( 24 ).…”

Section: Role Of Viral Resistance Testing In Hcv Treatmentmentioning

confidence: 99%

Role of Serologic and Molecular Diagnostic Assays in Identification and Management of Hepatitis C Virus Infection

et al. 2016

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The drugs available for the treatment of hepatitis C virus (HCV) have evolved to provide shorter treatment duration and higher rates of sustained virologic response (SVR), and the role of HCV infection diagnostic tests has had to evolve in order to meet changing clinical needs. This review gives an overview on the role of HCV infection diagnostic testing (molecular and serological tools) used in the diagnosis and management of HCV infection. All of this critical information guides physician decisions to optimize patient clinical outcomes. Also discussed is the future direction of diagnostic testing in the context of further advances in drug development.

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P1300 Efficacy and Safety of Daclatasvir in Combination With Asunaprevir (Dcv+asv) in Cirrhotic and Non-Cirrhotic Patients With HCV Genotype 1b: Results of the Hallmark Dual Study

Cited by 9 publications

References 0 publications

Pharmacokinetics, Efficacy, and Safety of Hepatitis C Virus Drugs in Patients with Liver and/or Renal Impairment

Pharmacokinetics, Efficacy, and Safety of Hepatitis C Virus Drugs in Patients with Liver and/or Renal Impairment

Interferon‐free, direct‐acting antiviral therapy for chronic hepatitis C

Role of Serologic and Molecular Diagnostic Assays in Identification and Management of Hepatitis C Virus Infection

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